Study Of Weight-Based Versus Standard Dose Enoxaparin Thromboprophylaxis In High-Risk Hospitalized Cancer Patients

Completed · Phase 2

Conditions studied: Venous Thormboembolism

In brief

Hospitalized patients with histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma, or multiple myeloma and who are at high risk for a venous thromboembolism will be randomized to standard dose versus intermediate dose enoxaparin.

Key facts

Study ID

NCT02706249

Run by

Dana-Farber Cancer Institute

People needed

50

Starts

2016-04-01

Expected to finish

2021-06-07

Last updated by the study team

2021-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have histologically or cytologically confirmed diagnosis of solid tumor malignancy, lymphoma or multiple myeloma.
• Cancer diagnosis or received treatment (chemotherapy or radiotherapy) for malignancy within the previous 6 months
• One or more Padua-based risk factor:
• History of previous venous thromboembolic event (excluding superficial vein thrombosis)
• Reduced mobility (ECOG performance status 3 or 4, see Appendix A)
• Established hereditary thrombophilia (e.g. Factor V Leiden, G20210 prothrombin mutation, protein C or S deficiency, antithrombin deficiency).
• Recent surgery within the last 30 days
• Age ≥ 70 years
• Congestive heart failure (NYHA class III or IV)
• Complicated respiratory insufficiency (defined as an increased requirement for supplementary oxygen of at least 2L)
• Acute myocardial infarction or ischemic stroke
• Obesity (BMI ≥ 30)
• Receiving hormonal agents (e.g. tamoxifen, estrogen, testosterone)
• Acute infection (i.e. requiring antimicrobial therapy)
• Age ≥ 18 years
• Life expectancy of greater than 30 days
• Platelet count ≥ 100,000/mcL
• Creatinine < 1.5 mg/dL or estimated creatinine clearance ≥ 50 mL/min/1.73 m2
• Ability to understand and the willingness to sign a written informed consent document
• Weight between 50kg to 130 kg.

You may not qualify if…

• History of allergic reactions attributed to heparin or low molecular weight heparin
• Active bleeding or otherwise considered high risk for hemorrhage (e.g. known acute gastrointestinal ulcer)
• Any history of significant hemorrhage (requiring hospitalization or transfusion) within the last 6 months (excluding hemorrhage during operative procedure).
• History of heparin induced Thrombocytopenia
• Presence of coagulopathy (PT or PTT> 1.2 x upper limit of normal)
• Known diagnosis of disseminated intravascular coagulation
• Currently receiving therapeutic anticoagulant therapy or dual antiplatelet therapy (eg. aspirin and clopidogrel)
• Uncontrolled arterial hypertension (systolic blood pressure > 200mmHg, diastolic >110mmHg)
• Active peptic ulcer disease
• Bacterial Endocardititis
• Received any type of Pharmacologic Thromboprophylaxis (e.g. low molecular weight heparin or heparin) for >48 hours during current hospitalization
• Known brain metastases

Where it is running

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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